Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants

Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.

This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: ultrasound

Detailed Description

There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.

The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.

• Study Type: Observational
• Enrollment (Actual): 63

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population are term pregnants posted for elective lower segment cesarean section and non-pregnant patients posted for elective surgeries in PGIMER.

Description

Inclusion Criteria:Study group- Term pregnant patients, aged between 18 to 45 years, ASA II & III, having BMI between 18.5 to 30 kg/m2, scheduled for elective lower segment cesarean section.

Control group- Non-pregnant female patients, aged between 18 to 45 years, ASA I & II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.

Exclusion Criteria:Subjects with-

• Gastrointestinal pathology
• On any medication delaying gastric motility
• Systemic lupus erythematosis
• Diabetes mellitus
• Gestational diabetes
• Hypothyroidism Those who were not willing to give consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant and non-pregnant females; The pregnant females posted for elective lower segment cesarean section and non-pregnant females posted for elective surgeries are scanned by ultrasound in the pre recovery room. The visibility of the gastric antrum is assessed. The qualitative and quantitative assessment is made and is compared.	Other: ultrasound; Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility	The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.	October 2016 to October 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of Gastric antrum	The qualitative grading is derived and is compared in the pregnants and non-pregnants.	October 2016 to October 2017
Quantitative assessment of Gastric Antrum	The quantitative data is obtained from the derived formulae and is compared in pregnants and non-pregnants.	October 2016 to October 2017

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Snigdha Bellapukonda, MBBS, Post graduate institute of medical education and researchh

Publications and helpful links

General Publications

• Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2016
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 10565/PG-2Trg/2015/173-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Ultrasound for comparison of Gastric volume in pregnants undergoing Elective Lower Segment Cesarean Section and non-pregnant females undergoing elective surgeries.
• IPD Sharing Time Frame: December 2017 to December 2018
• IPD Sharing Access Criteria: public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No